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Headlines Archive

FDA Approvals and Actions
Drug approvals, recalls and actions by the Food and Drug Administration.


FDA Drug Approvals & Actions

Electronic Device Tracks Surgical Cases
Ensures operation is done on correct patient

November 22, 2004

New Drug for Advanced Lung Cancer
Extended life for some in trials

November 19, 2004

Colon Cancer Drug Wins Additional Approval
OK to combine with chemo after tumor removal

November 5, 2004

Help for Dialysis Patients
New drug helps manage phosphorus levels

October 29, 2004

Artificial Spinal Disc Approved
To help ease lower back pain

October 27, 2004

Ultrasound Device Zaps Uterine Tumors
Not intended for childbearing women

October 22, 2004

Partial Artificial Heart Approved
For patients awaiting transplant

October 18, 2004

Implanted Medical-Records Chip Approved
Key information travels with you

October 13, 2004

Abilify Wins Approval for Bipolar Disorder
Calms uncontrolled mania

October 6, 2004

New Opioid Painkiller Approved
Labeling warns of potential for abuse

October 1, 2004

Nonprescription Defibrillators Approved
To regulate abnormal heartbeat

September 17, 2004

Anti-Snoring Device Approved for Sleep Apnea
Stiffens tissue in throat

September 15, 2004

Implanted Lens Corrects Nearsightedness
But trials unearth potential risk

September 13, 2004

Antidepressant Approved for Diabetes Pain
5 Milllion Americans May Benefit

September 7, 2004

New Stent System Helps Prevent Stroke
Thwarts blockages in neck artery that pumps blood to brain

August 31, 2004

Antipsychotic Drug Approved for Bipolar Mania
With less chance of weight gain, maker says

August 24, 2004

New Drugs Thwart Dirty Bomb Effects
Rid body of radioactive elements

August 13, 2004

Antidepressant Targets Two Brain Chemicals
New users should be monitored closely, FDA says

August 6, 2004

Drug Plumps Faces Drawn by HIV
Sculptra reverses gaunt appearance

August 5, 2004

New Anti-AIDS Combinations Approved
Patients take fewer pills

August 4, 2004

Lipitor Can Prevent Heart Attacks
Cholesterol drug approved for new use

August 3, 2004

Helping Alcoholics Stay Sober
Campral works to prevent relapses

August 2, 2004

Cholesterol-Lowering Combo Approved
Fights the artery clogging substance 2 ways

July 28, 2004

Botox OK'd for Excessive Sweating
Fourth approval for anti-wrinkle drug

July 21, 2004

Topical Cream for Skin Cancer
When surgery is less preferred

July 16, 2004

New Software Detects Lung Growths
Helps radiologists reading CT scans

July 14, 2004

Device Aids Coronary Bypasses
Gives surgeons use of 'robotic' arms

July 12, 2004

Appendicitis Diagnostic Test Approved
Checks for signs of infection

July 8, 2004

First Easy-to-Use Anthrax Test Approved
Results available in about an hour

June 30, 2004

FDA OKs Medicinal Use of Leeches
They sop up pooled blood

June 30, 2004

Overactive Bladder Drug Approved
Relaxes muscles, reducing contractions

June 1, 2004

Revenge on Montezuma's Revenge
New drug treats travelers' diarrhea

May 27, 2004

Drug Approved for Bone Marrow Disorders
Rare conditions could lead to leukemia

May 21, 2004

Breast Cancer Drug Gets Nod for Prostate Cancer
For cases that don't respond to hormone therapy

May 20, 2004

Enbrel Approved to Treat Psoriasis
Tames inflamed skin lesions

May 4, 2004

Drug Counters Immobility in Parkinson's Patients
But has its own side effects

April 22, 2004

Fast-Acting Insulin Wins OK
Helps diabetics manage hyperglycemia

April 20, 2004

New Antibiotic Fights Respiratory Infections
Leaves other bacteria alone

April 2, 2004

Injectable Zyprexa Approved
Suppresses acute agitation

March 31, 2004

Rapid HIV Test for Needle-Leery People
FDA approves test that uses outer gum cells

March 26, 2004

Generic Oxycontin Wins Approval
Will action invite more abuse?

March 24, 2004

New Drug Treats Overactive Parathyroid Gland
Regulates minerals in the body

March 9, 2004

First Cancer Drug That Cuts Off Blood Is OK'd
Prevents formation of new blood vessels

February 26, 2004

New Treatment for Enlarged Prostate
Better than medication, manufacturer says

February 19, 2004

Anti-Cancer Drug Wins OK on 2nd Try
At center of Martha Stewart scandal

February 12, 2004

New Drug for Rare Cancer
Usually related to asbestos exposure

February 5, 2004

Single Drug for Cholesterol, Blood Pressure Approved
Millions live with both

February 3, 2004

Sleep Disorder Drug Gets Nod
Keeps users awake

January 27, 2004

New Parkinson's Device Limits Surgery
Stimulates both sides of brain at once

January 23, 2004

Colon Cancer Drug Approved for Wider Use
Helps slow tumor growth, spread

January 12, 2004

New Drug Treats Bipolar Disorder
Combats bouts of severe depression

December 30, 2003

First Weight-Loss Drug for Children Approved
But can have significant side effects

December 16, 2003

European Wrinkle Smoother Approved
Joins Botox, Collegen

December 15, 2003

Agency Clears Anthrax Test
Helps doctors confirm infection

December 10, 2003

Gleevec Formally OK'd for Rare Cancer
Chronic Myeloid Leukemia

December 9, 2003

Manic Depression Drug Approved
A new use for Risperdal

December 8, 2003

New Drug Treats Advanced Prostate Cancer
But severe allergic reactions are possible

December 1, 2003

FDA Approves 3rd Impotence Drug
Cialis joins Viagra and Levitra

November 21, 2003

Breast Tumors Removed Without Major Surgery
FDA OKs biopsy device for new use

November 20, 2003

Stomach Relief for People With Chronic Pain
One prescription combines 2 popular drugs

November 20, 2003

FDA OKs 1st Chewable Contraceptive
Ovcon 35 has spearmint flavor

November 15, 2003

Psoriasis Drug Tames Immune Cells
Controls itchy, scaly skin

October 28, 2003

New AIDS Drug Clears
Fewer restrictions on use

October 21, 2003

New Alzheimer's Drug Approved
But it's no miracle cure

October 17, 2003

Paxil CR Approved for Social Anxiety Disorder
Longer-lasting version controls 'social phobia'

October 17, 2003

New Delivery System for Hepatitis C Drug
No syringe needed

October 14, 2003

New Skin Lotion for Hot Flashes
Will carry warnings of HRT risks

October 10, 2003

Hypertension Drug Approved for Post-Heart Attack Use
Reduces heart failure risk

October 8, 2003

Drug Approved for Radiation Exposure
May protect against components of so-called 'dirty bomb'

October 2, 2003

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